BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2102492 · Received May 20, 2011

    Report

    Report Number
    1828100-2011-01354
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 20, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE PRESSURE TRANSDUCER HOLDER HAD STRESS CRACKS. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 PRESSURE TRANSDUCER HOLDER DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 22300030

    Patients

    Seq Age Sex Outcome Treatment
    1